Breathe Technologies’ NIOV System has received a CE Mark for use in Europe. NIOV provides augmented tidal volume, which reduces the work of breathing for people with respiratory insufficiency caused by chronic obstructive pulmonary disease (COPD), including Alpha-1 Antitrypsin Deficiency.
The device is a one-pound noninvasive mechanical ventilator that can be used in homecare and institutional settings. The Breathe NIOV System utilizes novel venturi principle technology in a comfortable facial interface that can be worn while talking and exercising.
Breathe Technologies received US FDA 501(k) clearance in 2010 for the NIOV System.
“Receiving a CE Mark for our NIOV System is a significant milestone for Breathe Technologies and we appreciate the concurrent recognition from the European Respiratory Society,” said Larry Mastrovich, president and CEO, Breathe Technologies. “We are now exploring potential commercialization partners for the EU and developing a European advisory board.”
“Our experience with the Breathe Non-Invasive Open Ventilation System in the U.S. reaffirms the importance of ventilation with ambulation for people with respiratory insufficiency diseases including COPD,” said Larry C. Casey, MD, PhD, Mayo Clinic Health System, Franciscan Healthcare, La Crosse, Wisconsin. “I expect that the improvements in exercise duration and reduction in exacerbations seen among patients using the NIOV will resonate with physicians and patients in the EU.”